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iPhone Urinalysis App Draws U.S. Government Scrutiny

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Original poster
Apr 12, 2001
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The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone into a medical device, designed to read urinalysis test strips that are normally examined by users and compared to a color-coded chart.

With the uChek system, patients can take a picture of the strip with the iPhone's camera and then receive an automated readout of parameters like glucose, urobilinogen, pH, ketone and more. The app also stores results which then can be analyzed over time.

uchek.jpg
Though medical device makers have adopted the iPhone for some measurements like blood glucose monitoring for diabetics, large scale use of smartphones and tablets as a replacement for existing medical devices has yet to take off -- likely due in large part to government regulation of medical devices.

From Bloomberg:
Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone's camera to allow the system to processes and generate automated results.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.
Click to expand...
The uChek kit can be purchased in the US and India for $40, while the uCheck iPhone app is a free download [Direct Link] from the App Store -- though the app can also manually read urine strips from other companies.

Article Link: iPhone Urinalysis App Draws U.S. Government Scrutiny
 
Article Link
https://www.macrumors.com/2013/05/24/iphone-urinalysis-app-draws-u-s-government-scrutiny/
M

macaddict06

macrumors regular
Jan 17, 2006
202
132
about 3 meters from here. *points*
Good idea, but valid point

As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
 
TheRealTVGuy

TheRealTVGuy

macrumors 6502a
Jul 21, 2010
706
1,156
Orlando, FL
You want to make sure you're in the correct kind of light, and that the camera properly white balances before you accept the photo for analysis, that's for sure!
 
Sayer

Sayer

macrumors 6502a
Jan 4, 2002
981
0
Austin, TX
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
 
notjustjay

notjustjay

macrumors 603
Sep 19, 2003
6,056
167
Canada, eh?
macaddict06 said:
As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Click to expand...

Yeah, you don't want to piss anyone off! :eek: :D

But seriously, you're right. You don't want to rely on inaccurate results generated because your particular iPhone wasn't calibrated correctly or your room lighting was inadequate or whatever. A great idea, but we need to be careful.
 
C

cameronjpu

macrumors 65816
Aug 24, 2007
1,367
78
So… Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.
 
M

mytdave

macrumors 6502a
Oct 29, 2002
620
800
.|..

Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
 
N

neuropsychguy

macrumors 68020
Sep 29, 2008
2,379
5,650
macaddict06 said:
As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Click to expand...

Why should it need FDA approval? That's only really needed if it will be used by medical professionals as part of patient care. It people use it of their own accord as part of routine lab work, this doesn't need FDA approval. People just have to realize that while the results might be valid they should not replace care by a competent medical professional.

Medical professionals should not be using things like this without FDA approval (although there are a number of clinical lab tests that are not FDA-approved but are still frequently run; I was just reading a patient's chart where a number of standard labs had been run and a couple of them had large disclaimers that the test was not FDA-approved).
 
F

Fandongo

macrumors 6502
Nov 2, 2011
313
1
Space
notjustjay said:
Yeah, you don't want to piss anyone off! :eek: :D

But seriously, you're right. You don't want to rely on inaccurate results generated because your particular iPhone wasn't calibrated correctly or your room lighting was inadequate or whatever. A great idea, but we need to be careful.
Click to expand...

iObamacare :D.
 
APlotdevice

APlotdevice

macrumors 68040
Sep 3, 2011
3,145
3,861
TheRealTVGuy said:
You want to make sure you're in the correct kind of light, and that the camera properly white balances before you accept the photo for analysis, that's for sure!
Click to expand...

Aye. Personally I don't trust auto-WB for my own family photos, let alone medical results.
 
E

elvetio

macrumors member
May 29, 2012
84
0
,,,

these are the rules, if you want to innovate in this sector you have to lobby a few millions. no exceptions accepted guys.. you should know this by now
 
A

alent1234

macrumors 603
Jun 19, 2009
5,688
170
Sayer said:
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Click to expand...


how do you know the app's results are real without any testing or verification?
 
M

mudman2

macrumors member
Jul 19, 2010
95
0
This only makes any sense if the FDA undertake to test submitted apps for free since if you dont you limit the creation of apps to ..... wait for it.....

drug companies who can afford it
 
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